Field of the Disclosure
The present disclosure relates generally to the concurrent supporting of a plurality of containers for the storage of substances for medical, pharmaceutical or cosmetic applications, in particular of flasks (vials) and cartridges, and more particularly to the concurrent supporting of a plurality of containers in a transport and packaging container in such a manner that these can be further processed in filling units or processing units, in particular in a sterile tunnel, in a filling unit for liquid medical or pharmaceutical applications or in a freeze-dryer.
Background of the Related Art
Medication containers, for example vials, ampoules, syringes or cartridges, are widely used as containers for preservation and storage of medical, pharmaceutical or cosmetic preparations to be administered in liquid form, in particular in pre-dosed amounts. These generally have a cylindrical shape, can be made of plastic material or glass and are available in large quantities at low costs. In order to fill the containers under sterile conditions as efficiently as possible concepts are increasingly used according to which the containers are packaged under sterile conditions in a transport and packaging container already at the manufacturer of the containers, which are then unpacked and further processed under sterile conditions at a pharmaceutical company, in particular in a so-called sterile tunnel.
For this purpose, various transport and packaging containers are known from the prior art, in which a plurality of medication containers are concurrently arranged in a regular arrangement, for example in a matrix arrangement along rows and columns extending perpendicular thereto. This has advantages in the automated further processing of the containers since the containers can be passed to processing stations, for example to processing machines, robots or the like, at controlled positions and in a predetermined arrangement.
Such a transport and packaging container and a corresponding packaging concept are disclosed for example in U.S. Pat. No. 8,118,167 B2. The further processing of the containers is, however, always performed such that the supporting structure will be removed from the transport and packaging container, that the containers will be removed from the supporting structure and isolated and then individually placed on a conveyor, in particular a conveyor belt, and passed to the processing stations for further processing. This limits the speed of processing that can be achieved. Particularly in the isolation of the containers by means of cell wheels or the like, it always occurs that individual containers abut uncontrolled, which results in an undesired abrasion and subsequently in a contamination of the interior volume of the containers or of the processing station and in an impairment of the outer appearance of the containers, which is undesirable.
GB 2478703 A discloses a supporting structure for supporting a plurality of vials for applications in gas or liquid chromatography. The supporting structure consists of two plates in which a plurality of receptacles is formed for accommodating the vials therein, wherein the two plates can be folded to each other. The receptacles of the two plates are offset from one another, so that the containers are arranged in an interleaved manner to double the packing density and to enable a good access to the containers in the folded-in position. Measures for sealing the interior of a transport container formed by two plates are not disclosed.
Further transport and packing containers and supporting structures are disclosed by U.S. Pat. No. 8,100,263 B2, US 2011/0132797 A1, FR 2595667 and U.S. Pat. No. 832,086 A.
A direct contact with the bottoms of the medication containers is not possible with the conventional supporting structures. However, this impedes the further processing of the medication containers particularly when their content shall be subjected to a freeze-drying process (also known as lyophilization or sublimation drying). Furthermore, a further processing of the medication containers directly within the supporting structures is not possible, because they are supported there either rigidly or are not accessible to a sufficient extent for the further processing, which is the reason why conventionally the medication containers always need to be taken out of the supporting structures for further processing.
A fundamental problem in the production and processing containers for medical or pharmaceutical applications are contaminants, which are resistant to high temperatures, particularly endotoxins, the lysis of bacteria as well as a number of other substances inducing cytokines (CIS). Endotoxins (pyrogens) are lipopolysaccharides from the outer layers of the cell membrane of gram-negative bacteria, for example E. coli. In the parenteral administration in human beings endotoxins cause febrile reactions and thus must be avoided by all means. These contaminations naturally occur for example in bacterial fermentation processes, but can be transmitted in part by human beings themselves or by contaminated water systems in the production. Endotoxins are highly temperature resistant and withstand fluctuations in pH. To eliminate such contaminations very high temperatures must be used (especially above 300° C.). In this context, there is still room for improvement with regard to transport and packaging containers or supporting structures thereof, which accommodate or support the containers during their processing at high temperatures, and with regard to procedures for removing such contaminants in containers in a simple and cost-effective manner by processing at high temperatures.
The burning-in of silicones for fixing the silicone on the glass surface has proved to be advantageous to prevent such contaminations in containers for substances for medical or pharmaceutical applications, especially those made of glass. For this purpose, high temperatures of above 300° C. are necessary. For this purpose it is advantageous to carry out the processing of the glass body under clean room conditions. The siliconization provides a protective layer for drugs that are based on sensitive molecules, which can react to the glass container. In this context, there is still room for improvements with regard to transport and packaging containers or supporting structures thereof, which accommodate or support the containers during their processing and during the burning-in of silicone layers at high temperatures, and with regard to procedures for processing the containers and during the burning-in of silicone layers at high temperatures in a simple and cost-effective manner.